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Evaluation of eszopiclone and escitalopram oxalate co-therapy in patients with generalized anxiety disorder and insomnia

Published online by Cambridge University Press:  16 April 2020

S. Montgomery ,
G. Kinrys ,
A. Krystal ,
W.V. McCall ,
T. Roth ,
R. Rubens ,
K. Schaefer ,
J. Roach ,
H. Huang  and
R. Krishnan
...Show all authors
S. Montgomery
Affiliation:
Imperial College, London University, London, United Kingdom
G. Kinrys
Affiliation:
Cambridge Health Alliance & Harvard Medical School, Boston, MA, USA
A. Krystal
Affiliation:
Duke University Medical Center, Durham, NC, USA
W.V. McCall
Affiliation:
Wake Forest University Health Sciences, Winston-Salem, NC, USA
T. Roth
Affiliation:
Henry Ford Sleep Disorders Center, Detroit, MI, USA
R. Rubens
Affiliation:
Sepracor Inc., Marlborough, MA, USA
K. Schaefer
Affiliation:
Sepracor Inc., Marlborough, MA, USA
J. Roach
Affiliation:
Sepracor Inc., Marlborough, MA, USA
H. Huang
Affiliation:
Sepracor Inc., Marlborough, MA, USA
R. Krishnan
Affiliation:
Wake Forest University Health Sciences, Winston-Salem, NC, USA
M. Pollack
Affiliation:
Massachusetts General Hospital, Boston, MA, USA

Abstract

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Background:

We evaluated the efficacy of eszopiclone (ESZ) and concurrent escitalopram oxalate (EO) in patients with insomnia and co-morbid GAD.

Methods:

Patients meeting DSM-IV-TR criteria for GAD and insomnia received 10 weeks of EO 10mg and co-therapy with ESZ 3mg or placebo (PBO) for 8 weeks. For the last 2 weeks, ESZ was replaced with single-blind PBO to evaluate discontinuation effects. Sleep, daytime functioning and anxiety measures were captured during the study.

Results:

ESZ+EO improved sleep and daytime functioning at each week and the double-blind period average (p<0.05). At Week 8, significantly more ESZ+EO patients had no clinically meaningful insomnia based on ISI</=7. Significant improvements with ESZ+EO (relative to PBO+EO) were observed in HAM-A total scores each week, and Weeks 4-10 excluding the insomnia item. ESZ+EO was significantly better at every timepoint on CGI-I (p<0.02); CGI-S was not different between treatments after Week 1. Median time to anxiolytic response was reduced with ESZ+EO based on HAM-A and CGI-I. HAM-A response and remission rates at Week 8 were higher with ESZ+EO, and HAM-D17 scores were improved at all timepoints (p<0.004). After eszopiclone discontinuation, there was no evidence of rebound insomnia, and no treatment differences in sleep or daytime function. Significant treatment differences in anxiety and mood were maintained after discontinuation.

Conclusion:

In this study, ESZ+EO was well tolerated and associated with improved sleep and daytime function without evidence of tolerance. Improvements in anxiety and mood were observed with ESZ+EO.

Support for this study provided by Sepracor Inc., Marlborough, MA.

Type
Poster Session 2: Depressive Disorders
Information
European Psychiatry , Volume 22 , Issue S1: 15th AEP Congress - Abstract book - 15th AEP Congress , March 2007 , pp. S238 - S239
Copyright
Copyright © European Psychiatric Association 2007
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